Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation (MULTI-HEARTS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,440
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).
详细描述
Hypertension and diabetes frequently co-occur and together are a leading cause of death and disability. Despite the availability of effective treatments, many patients remain untreated or uncontrolled. HEARTS is a package of implementation strategies recommended by the World Health Organization and Pan American Health Organization to improve cardiovascular disease management in primary care. To date, most HEARTS projects have focused on hypertension alone, and rigorous evaluations of HEARTS for integrated hypertension and diabetes care are lacking.
This cluster-randomized trial will be conducted in 36 Ministry of Health primary care facilities (Health Centers) in Guatemala. Health Centers will be randomized 1:1 to HEARTS or enhanced usual care. The HEARTS intervention consists of five implementation strategies adapted to Guatemala: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols; (3) strengthening supply chains of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The comparator arm receives enhanced usual care, which includes standard Ministry of Health clinical care plus supply chain strengthening to ensure between-arm differences are not attributable to medication availability.
Approximately 1,440 patients with hypertension-diabetes multimorbidity (40 per facility) will be enrolled and assessed at baseline and 12 months. Co-primary outcomes are change in systolic blood pressure and hemoglobin A1c. Secondary outcomes include diastolic blood pressure, and proportions achieving blood pressure control (<130/<80 mmHg), hemoglobin A1c control (<7.0%), and combined control. A cost-effectiveness and budget impact analysis will be conducted from the health care sector perspective. The implementation period is 30 months, followed by a 12-month maintenance period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Systolic blood pressure ≥130 mmHg on ≥2 occasions, defined as the mean of 6 measurements at 2 study visits scheduled at least 1 day apart but within 7 days
- •Hemoglobin A1c ≥6.5%
- •Able and willing to provide informed consent
排除标准
- •Does not live in Health Center's catchment area or is unwilling to receive care at the Health Center
- •Currently pregnant or planning pregnancy in the next 2 years
- •Has been diagnosed with type 1 diabetes, or there is high suspicion of this diagnosis by study physicians
- •Has severe chronic or terminal illness such that primary care management of hypertension and/or diabetes would be clinically inappropriate, including end-stage kidney disease
- •Confined to bed
- •Planning to leave the study area in the next 2 years
- •Unwilling to comply with protocol requirements
研究组 & 干预措施
HEARTS Integrated Hypertension-Diabetes Care
Health Centers in the experimental arm receive a package of five multilevel HEARTS implementation strategies adapted to Guatemala for integrated hypertension-diabetes multimorbidity care: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols for hypertension and diabetes; (3) strengthening supply chains of a core set of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The implementation period is 30 months, followed by a 12-month maintenance period.
干预措施: HEARTS implementation strategies (Other)
HEARTS Integrated Hypertension-Diabetes Care
Health Centers in the experimental arm receive a package of five multilevel HEARTS implementation strategies adapted to Guatemala for integrated hypertension-diabetes multimorbidity care: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols for hypertension and diabetes; (3) strengthening supply chains of a core set of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The implementation period is 30 months, followed by a 12-month maintenance period.
干预措施: Supply chain strengthening (Other)
Enhanced Usual Care
Health Centers in the comparator arm receive enhanced usual care consisting of standard clinical care and medications for hypertension and diabetes available through the Ministry of Health system, aligned with national clinical guidelines. As an enhancement to usual care, comparator Health Centers also receive the strategy to strengthen supply chains of medications and supplies. This enhancement ensures that between-arm differences are not due to variations in clinical resource availability and minimizes the risk of contamination, as supply chain management in the MOH system occurs at multiple levels.
干预措施: Supply chain strengthening (Other)
结局指标
主要结局
Change in systolic blood pressure
时间窗: Enrollment to 12 months
Between-arm mean difference in change in systolic blood pressure (mmHg)
Change in hemoglobin A1c
时间窗: Enrollment to 12 months
Between-arm mean difference in change in hemoglobin A1c (%)
次要结局
- Change in diastolic blood pressure(Enrollment to 12 months)
- Proportion with blood pressure control(Enrollment to 12 months)
- Proportion with hemoglobin A1c control(12 months)
- Proportion with combined blood pressure and hemoglobin A1c control(12 months)
研究者
David Flood
Assistant Professor of Medicine
University of Michigan